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Active, Not Recruiting

NCT Number: NCT06576531

Exercise and Prediabetes After Renal Transplantation

The present clinical trial, EXPRED-II, is the continuation of EXPRED-I (NCT04489043).

Objective: to evaluate the feasibility of exercise in the reversibility of prediabetes after transplantation, as a first step to prevent Post-Transplant Diabetes Mellitus (PTDM).

Methodology: a total of 50 patients with prediabetes beyond 12 months after transplantation with capacity to perform exercise will be randomized to standard life-style recommendations as per clinical practice (n=25) or to a stepped ad-hoc designed training intervention (n=25). Prediabetes will be diagnosed based on fasting glucose levels and an Oral Glucose Tolerance Test (OGTT). Patients randomized to exercise will start with aerobic exercise training 5 times/week, 30 min/day for 12 months which may be gradually increased to 60 min/day or combined with strength exercise in the last increment in case of prediabetes persistence. The reversibility/persistence/relapse of prediabetes will be measured with fasting glucose and OGTT every 3 months. The study will last 12 months.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Kidney Transplantation Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of La Laguna

San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years
  • ≥ 12 months post kidney transplant
  • Stable renal function in the last 3-6 months
  • Prediabetes (abnormal fasting glucose 100-125 mg/dl and/or glucose intolerance 140-199mg/dl)
  • Ability to perform exercise

Exclusion criteria

  • Infection, cancer, acute cardiovascular disease, advanced kidney disease, pulmonary hypertension and uncontrolled chronic liver disease.
  • Inability to understand the protocol
  • Severe psychological illness
  • PTDM and/or DM prior to transplantation
  • Morbid obesity

Treatment and study plan

Therapeutic exercise

Other

A stepped training intervention designed ad hoc based on a combination of aerobic and strength exercises.

Primary outcomes

  1. Reversibility of pre-diabetes in kidney transplant population through therapeutic exercise

    Time frame: Baseline and every 3 months (up to 12 months)

    There is an exercise programme to test the impact of this treatment on the reversibility of prediabetes. Thus, the persistance of recurrency of prediabetes assessed by an oral glucose tolerance test (OGTT) at intermediate time points (0, 3, 6, 9 and 12 months) will be checked in order to increase the intensity and duration of exercise training.

Secondary outcomes

  1. Compliance

    Time frame: Baseline and every 1.5 months (up to 12 months)

    To ensure compliance, the following measures will be implemented: (a) contact by phone one time per week, (b) individual interview every month and a half to reinforce lifestyle changes and follow all recommended in the exercise prescription; (c) the use of a gadget (xiaomi mi band) to see daily routines of patients and every training prescription; this analyses the time, frequency, burned calories, velocity and distance, among others, to reach the established goal by the physiotherapist.

  2. Analytics

    Time frame: Baseline and every 3 months (up to 12 months)

    To evaluate the improvements in metabolic risk factors profile: obesity, triglycerides, blood pressure and HDL cholesterol.hemogram (hematocrit, haemoglobin, white blood count), biochemist tests: creatinine, HbA1c, total, LDL and HDL cholesterol, triglycerides, uric acid, hepatic enzymes (ASAT, ALAT), levels of immunosuppression, albumin, creatinine, albuminuria, proteinuria in an isolated urinary samples

  3. Anthropometric measures

    Time frame: Baseline and every 3 months (up to 12 months)

    At baseline and at 3, 6, 9, 12 months: weight in kilograms, height in meters, waist circumference, hip circumference, will be measured. Also, BMI Body mass index (BMI): weight in kilograms divided by the square of the height in meters.

Sponsors and collaborators

Lead sponsor

University of La Laguna

Other

Collaborators

  • Fundación Canaria Instituto de Investigación Sanitaria de Canarias

Registry information

Acronym: EXPRED-II

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 28, 2024
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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